Cleared Traditional

K210157 - SOLE Medial Column Fusion Plate

K210157 is the FDA 510(k) clearance for SOLE Medial Column Fusion Plate by Orthofix Srl. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K210157 · Orthofix Srl · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
89d
Days
Class 2
Risk

K210157 is an FDA 510(k) clearance for the SOLE Medial Column Fusion Plate. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Orthofix Srl (Bussolengo, IT). The FDA issued a Cleared decision on April 20, 2021 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthofix Srl devices

Submission Details

510(k) Number K210157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2021
Decision Date April 20, 2021
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Wagoner Consulting, LLC
Cheryl Wagoner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRS Plate, Fixation, Bone

All 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K210157.
DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)
K211051 · DePuy Synthes · Jun 2021
DRPx Locking Distal Radius Plate System
K202971 · Orthopaedic Implant Company · May 2021
JACE Medical Thoracic Plating System
K210290 · Jace Medical, LLC · Apr 2021
Volition Plating System
K210658 · Ortho Solutions UK , Ltd. · Apr 2021
DePuy Synthes Variable Angle Locking Patella Plating System
K210408 · Synthes USA Products, LLC · Apr 2021
DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
K210205 · Synthes USA Products, LLC · Mar 2021